Method and apparatus for inserting biopsy site marker in marker body

ABSTRACT

An apparatus for inserting a marking element into a marker body includes a body portion, an insertion member, and a pushing member. The body portion has a compartment configured to receive a marker body. The insertion member is configured to engage the marker body within the compartment. The pushing member is configured to engage with the insertion member. The pushing member is operable to force a marking element along the insertion member into the marker body. The insertion member may include a hollow needle configured to penetrate the marker body. The pushing member may include a pin configured to fit within the hollow needle. The marker body may include an opening such as a slit, a slot, or a passage that is configured to receive a marking element. The marker body may include a collagen dowel, and the marking element may be formed of titanium.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. An exemplary biopsydevice is the MAMMOTOME device from Ethicon Endo-Surgery, Inc. ofCincinnati, Ohio. Biopsy devices may be used under stereotacticguidance, ultrasound guidance, MRI guidance, or otherwise. Furtherexemplary biopsy devices are disclosed in U.S. Pat. No. 5,526,822,entitled “Method and Apparatus for Automated Biopsy and Collection ofSoft Tissue,” issued Jun. 18, 1996; U.S. Pat. No. 6,086,544, entitled“Control Apparatus for an Automated Surgical Biopsy Device,” issued Jul.11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRI Compatible SurgicalBiopsy Device,” published Jun. 12, 2003; U.S. Pub. No. 2007/0118048,entitled “Remote Thumbwheel for a Surgical Biopsy Device,” published May24, 2007; U.S. Provisional Patent Application Ser. No. 60/869,736,entitled “Biopsy System,” filed Dec. 13, 2006; U.S. Provisional PatentApplication Ser. No. 60/874,792, entitled “Biopsy Sample Storage,” filedDec. 13, 2006; and U.S. Non-Provisional patent application Ser. No.11/942,785, entitled “Revolving Tissue Sample Holder for Biopsy Device,”filed Nov. 21, 2007. The disclosure of each of the above-cited U.S.Patents, U.S. Patent Application Publications, U.S. Provisional PatentApplications, and U.S. Non-Provisional Patent Application isincorporated by reference herein.

In some settings, it may be desirable to mark the location of a biopsysite for future reference. For instance, one or more markers may bedeposited at a biopsy site before, during, or after a tissue sample istaken from the biopsy site. Exemplary marker deployment tools includethe MAMMOMARK, MICROMARK, and CORMARK devices from Ethicon Endo-Surgery,Inc. of Cincinnati, Ohio. Further exemplary devices and methods formarking a biopsy site are disclosed in U.S. Pub. No. 2005/0228311,entitled “Marker Device and Method of Deploying a Cavity Marker Using aSurgical Biopsy Device,” published Oct. 13, 2005; U.S. Pat. No.6,996,433, entitled “Imageable Biopsy Site Marker,” issued Feb. 7, 2006;U.S. Pat. No. 6,993,375, entitled “Tissue Site Markers for In VivoImaging,” issued Jan. 31, 2006; U.S. Pat. No. 7,047,063, entitled“Tissue Site Markers for In Vivo Imaging,” issued May 16, 2006; U.S.Pat. No. 7,229,417, entitled “Methods for Marking a Biopsy Site,” issuedJun. 12, 2007; U.S. Pat. No. 7,044,957, entitled “Devices for Definingand Marking Tissue,” issued May 16, 2006; U.S. Pat. No. 6,228,055,entitled “Devices for Marking and Defining Particular Locations in BodyTissue,” issued May 8, 2001; and U.S. Pat. No. 6,371,904, entitled“Subcutaneous Cavity Marking Device and Method,” issued Apr. 16, 2002.The disclosure of each of the above-cited U.S. Patents and U.S. PatentApplication Publications is incorporated by reference herein.

While several systems and methods have been made and used for marking asite within a patient, it is believed that no one prior to the inventorshas made or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a perspective view of an exemplary marker deploymenttool;

FIG. 2 depicts a partial cross-sectional view of the marker deploymenttool of FIG. 1 inserted in an exemplary biopsy device, deploying amarker;

FIG. 3 depicts a partial cross-sectional view of an exemplarymodification to the distal end of the marker deployment tool of FIG. 1;

FIG. 4 depicts a partial cross-sectional view of another exemplarymodification to the distal end of the marker deployment tool of FIG. 1;

FIG. 5 depicts a partial cross-sectional view of another exemplarymodification to the distal end of the marker deployment tool of FIG. 1;

FIG. 6 depicts a partial cross-sectional view of another exemplarymodification to the distal end of the marker deployment tool of FIG. 1;

FIG. 7 depicts a partial cross-sectional view of another exemplarymodification to the distal end of the marker deployment tool of FIG. 1;

FIG. 8 depicts a partial view of another exemplary modification to thedistal end of the marker deployment tool of FIG. 1;

FIGS. 9A-9C depict perspective, plan, and end views of an exemplarymarker;

FIGS. 10A-10C depict perspective, plan, and end views of anotherexemplary marker;

FIGS. 11A-11C depict perspective, plan, and end views of anotherexemplary marker;

FIGS. 12A-12C depict perspective, plan, and end views of anotherexemplary marker;

FIGS. 13A-13C depict perspective, plan, and end views of anotherexemplary marker;

FIGS. 14A-14C depict perspective, plan, and end views of anotherexemplary marker;

FIGS. 15A-15C depict perspective, plan, and end views of anotherexemplary marker;

FIG. 16 depicts cross sectional views of components of an exemplarydevice for inserting a marker element into a marker body

FIG. 17 depicts the device of FIG. 16 in an exemplary first stage ofuse;

FIG. 18 depicts the device of FIG. 16 in an exemplary second stage ofuse; and

FIG. 19 depicts the device of FIG. 16 in an exemplary third stage ofuse.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

As shown in FIG. 1, an exemplary marker applier (10) includes anelongate outer cannula (12) having a transverse opening (14) formed nearits distal end. The distal end of cannula (12) comprises a closed tip(22). A grip (16) is provided at the proximal end of cannula (12).Cannula (12) and tip (22) may be formed of PEBAX, any suitable polymer,metals, or any other suitable materials, including combinations thereof.A rod (18) is inserted in cannula (12) and is configured to translatewithin cannula (12). Rod (18) has sufficient rigidity to push a marker(30) out through opening (14) as will be described in greater detailbelow. However, rod (18) and cannula (12) are nevertheless flexible inthis example. A plunger (20) is provided at the proximal end of rod (18)for forcing rod (18) distally in cannula (12). In particular, a user maygrasp grip (16) with two fingers, and may push on plunger (20) using thethumb on the same hand, such that applier (10) may be operated by auser's single hand. A spring (not shown) or other feature may beprovided about rod (18) to bias rod (18) proximally.

Marker applier (10) may be used to deploy a marker (30) via opening (14)within tissue, such as to mark a particular location within a patient.By way of example only, a marker (30) may mark the site of a biopsy. Ofcourse, there may be a variety of other contexts for marking a locationin a patient's body. In the present example, however, marker applier(10) is introduced to a biopsy site using the same instrument or biopsydevice that was used to collect a tissue sample from the biopsy site.Several such biopsy devices are disclosed in the various patents andpatent applications that have been referred to and incorporated byreference herein, though any other biopsy devices may be used.

An exemplary use of a marker applier (10) is shown in FIG. 2. Inparticular, FIG. 2 shows the distal end of a marker applier (10)disposed within the outer needle (24) of a biopsy device. The outerneedle (24) has a tissue piercing tip (26) and a transverse opening (28)proximal to the tip (26). In the present example, needle (24) andapplier (10) are configured such that opening (14) of cannula (12) andopening (28) of needle (24) will be substantially aligned when cannula(12) is inserted in needle (24). In other words, opening (14) of cannula(12) is positioned relative to opening (28) of needle (24) such that amarker (30) may be deployed through both openings (14, 28). To deploymarker (30), a user actuates plunger (20), driving rod (18) distally.Tip (22) of marker applier (10) includes a proximally facing rampedsurface (23), which urges marker (30) outwardly through openings (14,28) and into the biopsy site as rod (18) is driven distally.

Marker (30) of the present example comprises a marker body (32) and amarking element (34). In some versions, marker body (32) is visibleunder ultrasound imaging, while marking element (34) is visible underMRI and X-ray, among other imaging modalities. For instance, marker body(32) may be formed of bovine collagen, cellulose, PLA/PGA, glycoprene,gelatinous materials such as hydrogel, and/or any other suitablematerial(s), including combinations thereof. Furthermore, marker body(32) may be biodegradable or bioapsorbable, or may have otherproperties. Marking element (34) may comprise a titanium wire, pellet,or other structure. Of course, any other material(s) may be used formarking element (34), including combinations thereof. In some versions,marker body (32) is formed of a square collagen pad that is foldedand/or rolled about a titanium marking element (34) to form asubstantially cylindraceous marker (30). Marker (30) is then compressedradially inward in this example before being inserted into cannula (12)to load marker applier (10) for deployment. Of course, marker (30) mayhave a variety of alternative configurations, may be formed using avariety of techniques, and may be used in a variety of other ways.Several merely illustrative examples of such variations will bedescribed in greater detail below.

I. Marker Applier Distal End Variations

It will be appreciated in view of the teachings herein that a markerapplier (10) may take a variety of forms and have a variety ofconfigurations. Several such configurations will be described in greaterdetail below, while others will be apparent to those of ordinary skillin the art in view of the teachings herein.

As shown in FIG. 3, one merely exemplary modification to a markerapplier (10) may include a distally facing ramped surface (40) on thedistal end of rod (18). Suitable angles for ramped surface (40) will beapparent to those of ordinary skill in the art in view of the teachingsherein. In the present example, tip (22) has a substantially flatproximally facing inner face (42). As rod (18) is driven distally by auser actuating plunger (20), ramped surface (40) engages marker (30). Asmarker (30) is engaged by both ramped surface (40) of rod (18) on oneend and by flat inner face (42) of tip (22) on the other end, marker(30) is urged outwardly (e.g., radially outwardly) from cannula (12) viaopening (14) into a site within a patient.

A similar variation of marker applier (10) is shown in FIG. 4. In thisexample, marker applier (10) also includes a ramped surface (40) on thedistal end of rod (18). In addition, tip (22) has a substantially flatinner face (42). However, marker (30) has an angled end (36) in thisexample. Suitable angles for angled end (36) will be apparent to thoseof ordinary skill in the art in view of the teachings herein. Angled end(36) may be formed in a variety of ways. For instance, angled end (36)may be substantially conical or frusto-conical. Alternatively, angledend (36) may be formed of two or more planar faces that converge at acommon edge, face, or point. Other ways in which an angled end (36) of amarker (30) may be provided will be apparent to those of ordinary skillin the art in view of the teachings herein.

In the present example, angled end (36) is configured to interact withramped surface (40) of rod (18). In particular, as rod (18) is drivendistally by a user actuating plunger (20), ramped surface (40) engagesangled end (36) of marker (30). As marker (30) is engaged by both rampedsurface (40) of rod (18) on angled end (36) end and by flat inner face(42) of tip (22) on the other end, marker (30) is urged outwardly (e.g.,radially outwardly) from cannula (12) via opening (14) into a sitewithin a patient.

Another variation of marker applier (10) is shown in FIG. 5. In thisexample, rod (18) has a substantially flat distal end (44) that issubstantially parallel to the flat inner face (42) of tip (22).Alternatively, distal end (44) and/or inner face (42) may be ramped orhave some other configuration. Marker (30) in this example has arecessed region (38) at its approximate center. Recessed region (38) maybe formed about the entire circumference of marker (30). Alternatively,recessed region (38) may be formed of two or more substantially planarfaces that converge at a common circumferential region. Other ways inwhich recessed region (38) may be configured will be apparent to thoseof ordinary skill in the art in view of the teachings herein. Recessedregion (38) may be formed by cutting or otherwise removing material frommarker body (32). Alternatively, recessed region (38) may be formed bycompressing or crimping the center of marker body (32). Other ways inwhich recessed region (38) may be formed will be apparent to those ofordinary skill in the art in view of the teachings herein.

In the present example, marker (30) is configured such that, as rod (18)is driven distally, squeezing marker (30) between distal end (44) of rod(18) and inner face (42) of tip (22), marker body (32) bends or bucklesat recessed region (38). Such bending may cause marker (30) to “pop out”of opening (14), thereby exiting cannula (12) into a biopsy site. Inaddition or in the alternative, such bending may cause marker body (32)to break in half and “pop out” of opening (14), thereby exiting cannula(12) into a biopsy site.

Yet another variation of marker applier (10) is shown in FIG. 6. In thisexample, rod (18) has a substantially flat distal end (44), similar tothe rod (18) shown in FIG. 5. Tip (22) has a ramped surface (23),similar to the tip (22) shown in FIG. 2. However, a thin plastic sheath(50) is provided about cannula (12) in this example. In particular,sheath (50) is disposed about the exterior of cannula (12), includingtip (22). A portion of sheath (50) is recessed within opening (14) toprovide a compartment (52), with marker (30) being carried external tosheath (50) within compartment (52). As rod (18) is driven distally,distal end (44) of rod (18) engages sheath (50), which urges marker (30)outwardly. In addition to or in lieu of distal movement of rod (18) todeploy marker (30), a portion of sheath (50) may be retracted proximallyto urge marker (30) outwardly. For instance, a collar (not shown) orother component may be secured to sheath (50), such as near grip (16) ofmarker applier (10). Proximal retraction of sheath (50) (e.g., bypulling a collar proximally) may cause sheath (50) to becomesubstantially taut. Such an increase in tightness of sheath (50) maydraw compartment (52) outward, thereby urging marker (30) outward. Ofcourse, sheath (50) may be provided and used in a variety of other ways,and may be incorporated with any of the other variations of markerapplier (10) and markers (30) described herein.

Yet another variation of marker applier (10) is shown in FIG. 7. In thisexample, rod (18) has a substantially flat distal end (44), similar tothe rod (18) shown in FIGS. 5-6. However, cannula (12) has an open andcurved distal end (60) in this example. Distal end (60) of cannula (12)is configured such that, as rod (18) is driven distally, distal end (44)of rod (18) pushes marker (30) out through open distal end (60) ofcannula (12) and into a biopsy site or other location within a patient.Rod (18) may have sufficient flexibility to substantially follow atleast a portion of the curvature of distal end (60) of cannula (12) asrod (18) is driven distally within cannula (12). Alternatively, cannula(12), marker (30), and/or rod (18) may be configured such that rod (18)does not need to follow any portion of the curvature of distal end (60)in order to deploy marker (30).

In addition, distal end (60) of cannula (12) may be have sufficientresilience to allow cannula (12) to be advanced distally through abiopsy needle (24), such that distal end (60) is relatively straightenedas cannula (12) is advanced within biopsy needle (24). When distal end(60) reaches opening (28) of biopsy needle (24), distal end (60) maythen “pop” outward, due to the resiliency of the material forming distalend (60). Distal end (60) may thus re-form back to a curvedconfiguration upon reaching opening (28) of biopsy needle (24). In someversions, cannula (12) is molded with distal end (60) in a curvedconfiguration to provide such resilience. Other ways of configuring andforming distal end (60) will be apparent to those of ordinary skill inthe art in view of the teachings herein. In addition, a suitable radiusof curvature or other form of curvature for distal end (60) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Still another version of marker applier (10) is shown in FIG. 8. In thisexample, cannula (12) comprises a leaf spring (60) near tip (22). Whenbowed concavely inward, as shown in FIG. 8, leaf spring (60) forms acompartment (62) in which marker (30) is disposed. Leaf spring (60) maybe formed by the same material that forms the remainder of cannula (12)(e.g., PEBAX, any suitable plastic, etc.), and/or may be unitarilyformed with cannula (12). Alternatively, leaf spring (60) may be formedseparately (e.g., formed of metal, some other plastic, etc.) and securedto cannula (12).

As shown in FIG. 8, leaf spring (60) is in a concave configuration,forming compartment (62), and storing potential energy. Upon sufficientactuation, however, leaf spring (60) “pops” outward to a convexconfiguration, thereby deploying marker (30) into a biopsy site or otherlocation within a patient. An exemplary convex configuration of leafspring (60) is shown by dashed line (64) in FIG. 8.

Leaf spring (60) may be actuated in a number of ways, such as byinducing buckling of leaf spring (60). For instance, rod (18) may bedriven distally using plunger (20), thereby driving distal end (44) ofrod (18) into leaf spring (60) to actuate leaf spring (60). Of course,rod (18) having a ramped surface (40) may also be used. Alternatively,the entire cannula (12) may be driven distally (e.g., by urging grip(16) distally), thereby driving tip (22) into the proximal face (27) oftip (36) of needle (24) of a biopsy device. Such driving of tip (22)into proximal face (27) may cause leaf spring (60) to buckle, therebyactuating leaf spring (60) into a convex configuration. An applier (10)may thus lack a rod (18), among other components, altogether. Stillother ways in which leaf spring (60) may be actuated to deploy a marker(30) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

Any of the foregoing variations of a marker applier (10) may be engagedwith a biopsy device in a variety of ways. In particular, a biopsydevice may be configured to accept a marker applier (10) while at leasta portion of the biopsy device is still inserted within a patient. Inother words, a biopsy device may be used to acquire a tissue sample, anda marker applier (10) may be introduced through the biopsy devicewithout having to withdraw or re-insert the biopsy device in tissue. Forinstance, a biopsy device may include an opening in the side of itshousing, permitting a user to insert cannula (12) of marker applier (10)through the side opening and through the needle (24) of the biopsydevice. A biopsy device may also include a passageway formed in aproximal portion of the biopsy device (e.g., a passageway coaxiallyaligned with needle (24)), permitting a user to insert cannula (12) ofmarker applier (10) through the proximal passageway and into the needle(24) of the biopsy device. A merely illustrative example of such aproximal passageway is disclosed in U.S. Non-Provisional applicationSer. No. 11/942,791, entitled “Deployment Device Interface for BiopsyDevice,” filed Nov. 20, 2007, the disclosure of which is incorporated byreference herein. Still other ways in which a marker applier (10) may beused in conjunction with a biopsy device will be apparent to those ofordinary skill in the art in view of the teachings herein.Alternatively, a marker applier (10) may be used separately from abiopsy device, or in other procedures altogether.

II. Marker Body Variations

It will also be appreciated in view of the teachings herein that amarker (30) may take a variety of forms and have a variety ofconfigurations. Several such configurations will be described in greaterdetail below, while others will be apparent to those of ordinary skillin the art in view of the teachings herein. In some versions of theexamples shown in FIGS. 9-15 and described in greater detail below, themarker bodies are formed as collagen dowels, with marking elementsinserted or otherwise disposed therein. However, it should be understoodthat a variety of other materials may be used to form the marker bodies.Furthermore, it should be understood that marking elements may bedisposed on the outside of the marker bodies, in addition to or in lieuof marking elements being disposed within the marker bodies.

As shown in FIGS. 9A-9C, a marker body (100) comprises a dowel of bovinecollagen. Marker body (100) has a substantially cylindraceous form,without cuts or slots being formed therein. A marking element (34) maybe inserted within marker body (100) and/or located external to markerbody (100) (e.g., wrapped around marker body (100), etc.). For instance,a marking element (34) may be inserted within marker body (100) usinginsertion device (200) described in greater detail below with referenceto FIGS. 16-19 or using any other suitable devices or techniques. Insome versions, after a marking element (34) has been inserted withinmarker body (100) and/or positioned about marker body (100), marker body(100) is compressed radially inward. Compression may also be applied toboth ends (102, 104) of marker body (100). Marker body (100) is thenpositioned within cannula (12) of a marker applier (10), ready fordeployment in a biopsy site or other location within a patient. Suitablelengths and diameters for marker body (100), as well as suitable methodsof making a collagen dowel or other forms of marker body (100), will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Another exemplary marker body (110) is shown in FIGS. 10A-10C. In thisexample, marker body (110) also comprises a collagen dowel, similar tomarker body (100) described above, though other materials may be used asnoted above. However, maker body (110) also has a longitudinal slit(116) formed therein. Slit (116) extends longitudinally from one end(112) of marker body (110) to another end (114) of marker body (110);and radially from the external surface of marker body (110) to thecenter of marker body (110). Slit (116) may be formed by cutting markerbody (110), by crimping marker body (110), or using any other suitabletechnique. As best seen in FIG. 10C, slit (116) provides a profile ofmarker body (110) similar to a PAC-MAN character.

Slit (116) may be configured to facilitate incorporation of a markingelement (34) into marker body (110). For instance, marker body (110) maybe “opened” at slit (116), and a marking element (34) may then beinserted in slit (116), with marker body (110) then being “closed” atslit (116). Marker body (110) may then be compressed as noted above withrespect to marker body (100). Alternatively, a marking element (34) maybe inserted from an end (112, 114) of marker body (110) and/or may beinserted after marker body (110) is compressed. Other suitable ways inwhich one or more marking elements (34) may be incorporated with markerbody (110) will be apparent to those of ordinary skill in the art inview of the teachings herein.

FIGS. 11A-11C show yet another merely exemplary marker body (120). Inthis example, marker body (120) also comprises a collagen dowel, similarto marker body (100) described above, though other materials may be usedas noted above. A slot (126) is formed in marker body (120). Thelongitudinal boundaries of slot (126) are between ends (122, 124) ofmarker body (120), such that slot (126) does not extend along the fulllength of marker body (120). While slot (126) is shown as beingapproximately centered between ends (122, 124), opening (126) may haveany other suitable longitudinal position. Slot (126) extends radiallyfrom the external surface of marker body (120) to the center of markerbody (120). Alternatively, slot (126) may pass through marker body (120)entirely (e.g., extending along the full diameter of marker body (120)).

Slot (126) may be formed by cutting marker body (120), by punchingmarker body (120), or using any other suitable technique. Slot (126) inthis example provides a region in which a marking element (34) may beinserted or otherwise positioned. In some versions, a piece (not shown)of marker body (120) is removed from marker body (120) to create slot(126), and that piece is replaced in slot (126) after marking element(34) is positioned in slot (126). In addition or in the alternative,marker body (120) may be compressed as described above before or after amarking element (34) is positioned in slot (126). Other suitable ways inwhich one or more marking elements (34) may be incorporated with markerbody (120) will be apparent to those of ordinary skill in the art inview of the teachings herein.

FIGS. 12A-12C show yet another merely exemplary marker body (130). Inthis example, marker body (130) also comprises a collagen dowel, similarto marker body (100) described above, though other materials may be usedas noted above. Marker body (130) includes a transverse opening (136)formed therein. Transverse opening (136) is located between ends (132,134) of marker body (130), and radially extends from the externalsurface of marker body (130) to the center of marker body (130). Whileopening (136) is shown as being approximately centered between ends(132, 134), opening (136) may have any other suitable longitudinalposition.

Opening (136) may be formed by drilling marker body (130), by punchingor poking marker body (130), or using any other suitable technique.Opening (136) in this example provides a region in which a markingelement (34) may be inserted or otherwise positioned. A marking element(34) may be introduced to opening (136) transversely relative to markerbody (130) or longitudinally relative to marker body (130). Marker body(130) may be compressed as described above before or after a markingelement (34) is positioned in opening (136). Other suitable ways inwhich one or more marking elements (34) may be incorporated with markerbody (130) will be apparent to those of ordinary skill in the art inview of the teachings herein.

FIGS. 13A-13C show yet another merely exemplary marker body (140). Inthis example, marker body (140) also comprises a collagen dowel, similarto marker body (100) described above, though other materials may be usedas noted above. In addition, marker body (140) has a transverse opening(146) positioned between ends (142, 144), similar to marker body (130)described above. However, unlike opening (136) of marker body (130),opening (146) of marker body (140) extends fully through marker body(140). Marker body (140) is otherwise substantially the same as markerbody (130), and may incorporate a marking element (34) in the same waysas marker body (130) as noted above.

FIGS. 14A-14C show yet another merely exemplary marker body (150). Inthis example, marker body (150) also comprises a collagen dowel, similarto marker body (100) described above, though other materials may be usedas noted above. Marker body (150) includes a longitudinal opening (156)formed therein. Longitudinal opening (156) extends from one end (152) ofmarker body (150) to the center of marker body (150), without reachingthe other end (154) of marker body (150). While opening (156) is shownas being positioned along the axis defined by marker body (150), opening(156) may have any other suitable position.

Opening (156) may be formed by drilling marker body (150), by punchingor poking marker body (150), or using any other suitable technique.Opening (156) in this example provides a region in which a markingelement (34) may be inserted or otherwise positioned. A marking element(34) may be introduced to opening (156) transversely relative to markerbody (150) or longitudinally relative to marker body (150). Marker body(150) may be compressed as described above before or after a markingelement (34) is positioned in opening (156). Other suitable ways inwhich one or more marking elements (34) may be incorporated with markerbody (150) will be apparent to those of ordinary skill in the art inview of the teachings herein.

FIGS. 15A-15C show yet another merely exemplary marker body (160). Inthis example, marker body (160) also comprises a collagen dowel, similarto marker body (100) described above, though other materials may be usedas noted above. In addition, marker body (160) has a longitudinalopening (166) formed therein, similar to marker body (150) describedabove. However, unlike opening (156) of marker body (150), opening (166)of marker body (160) extends fully through the length of marker body(160) (i.e., from end (162) to end (164)). Marker body (160) isotherwise substantially the same as marker body (150), and mayincorporate a marking element (34) in the same ways as marker body (150)as noted above.

The foregoing examples include a few of many different possiblevariations of a marker body (32). Still further variations of markerbody (32) will be apparent to those of ordinary skill in the art in viewof the teachings herein. In addition, while a single marker (30) isloaded in a marker applier (10) in the present example, it should beunderstood that a plurality of markers (30) may be loaded in a markerapplier (10). For instance, each marker (30) in such a plurality mayhave characteristics that differ from other markers (30) in theplurality (e.g., different materials, different sizes, different shapes,different imageability, etc.). Alternatively, some or all of the markers(30) in such a plurality may have substantially the same if notidentical characteristics. A plurality of markers (30) in a markerapplier (10) may be deposited in the same biopsy site or other locationwithin a patient, or they may be deposited in different locations withinthe patient.

III. Insertion of Marker into Marker Body

It will also be appreciated in view of the teachings herein that avariety of devices and techniques may be used to provide a markingelement (34) within a marker body (30). A merely exemplary device (200)and technique will be described in greater detail below, while otherswill be apparent to those of ordinary skill in the art in view of theteachings herein.

As shown in FIGS. 16-19, a device (200) for inserting a marking element(34) in a marker body (32) includes a base member (210), a plug (230), aneedle member (250), and a plunger (270). Base member (210) comprises abase portion (212) and a neck portion (214). A plug opening (216) isformed in the base portion (212). Plug opening (216) is configured toreceive plug (230) as will be described in greater detail below. Amarker opening (218) is also formed in base portion (212). Markeropening (218) is configured to receive a marker body (32) as will bedescribed in greater detail below. Plug opening (216) has a greaterdiameter than marker opening (218) in this example, though in otherversions, marker opening (218) may have the greater diameter, oropenings (216, 218) may have substantially the same diameter. Neckportion (214) has a neck opening (220) formed therein, and has achamfered edge (222). Of course, edge (222) need not necessarily bechamfered, and may be rounded, squared, or have any other suitableconfiguration. In addition, while openings (216, 218, 220) are allcoaxially aligned in this example, openings (216, 218, 220) may have anyother suitable relationships. For instance, marker opening (218) may besubstantially perpendicular to neck opening (220).

Plug (230) of the present example comprises a generally circular head(232) and a stem (234). Head (232) has a diameter that is substantiallyequal to or less than the diameter of plug opening (216) in thisexample. Stem (234) has a diameter that is substantially equal to orless than the diameter of marker opening (218) in this example. Inaddition, plug (230) has a length that is greater than the length ofplug opening (216). Accordingly, and as shown in FIG. 17, plug (230) maybe inserted in plug opening (216), such that a portion of stem (234)extends into marker opening (218). This fit between plug (230) and basemember (210) may be snug or loose, as desired. Alternatively, plug (230)and base member (210) may have any other suitable relationship.

Needle member (250) of the present example comprises a body (252), a topopening (254), and a hollow needle (256) that is positioned within andextends from body (252). Top opening (254) forms a funnel-like structureleading to the interior opening of hollow needle (256). A set screw(258) is positioned transverse to needle (256), and is operable tosecure the longitudinal position of needle (256) relative to body (252).In other words, the longitudinal position of needle (256) relative tobody (252) is adjustable in this example. Of course, set screw (258) maybe eliminated, such that the longitudinal position of needle (256)relative to body (252) is substantially fixed, or any other suitablestructures may be used.

Needle member (250) has a diameter that is substantially equal to orless than the diameter of neck opening (220) in this example. Needlemember (250) may thus be inserted in neck opening (220). In addition,the lengths of neck opening (220), body (252), and needle (256) are suchthat needle (256) will extend into marker opening (218) when needlemember (250) is inserted in neck opening (220), as shown in FIG. 18. Thefit between needle member (250) and neck opening (220) may be snug orloose, as desired. Alternatively, needle member (250) and base member(210) may have any other suitable relationship.

Plunger (270) of the present example comprises a body (272), a hollowinterior portion (274), and a pin (276). Pin (276) is centered withinhollow interior portion (274), and extends from body (272). A set screw(278) is positioned transverse to pin (276), and is operable to securethe longitudinal position of pin (276) relative to body (272). In otherwords, the longitudinal position of pin (276) is adjustable in thisexample. Of course, set screw (278) may be eliminated, such that thelongitudinal position of pin (276) relative to body (272) issubstantially fixed, or any other suitable structures may be used.

Hollow interior portion (274) has a diameter that is substantially equalto or greater than the diameter of neck portion (214) in this example.Pin (276) has a diameter that is less than the inner diameter of hollowneedle (256). Plunger (270) may thus be coupled with neck portion (256),such that hollow interior portion (274) receives neck portion (214).Chamfered edge (222) may facilitate such coupling. In addition, thelengths of neck portion (214), hollow interior portion (274), and pin(276) are such that pin (276) will extend through needle (256) whenplunger (270) is coupled with neck portion (256), as shown in FIG. 19.In particular, pin (276) extends completely through needle (256) in thisexample. The fit between plunger (270) and neck portion (214) may besnug or loose, as desired. Alternatively, plunger (270) and base member(210) may have any other suitable relationship.

A series of steps in an exemplary use of marker insertion device (200)are illustrated in FIGS. 17-19. It should be noted that, while a markerbody (32) is shown in each of FIGS. 17-19, marker body (32) is shown incross-section in FIGS. 18-19 but not in FIG. 17. First, as shown in FIG.17, plug (230) may be positioned in base member (210). After plug (230)has been positioned in base member (210), a marker body (32) is insertedinto marker opening (218), as also shown in FIG. 17. This fit betweenmarker body (32) and marker opening (218) may be snug or loose, asdesired. Alternatively, marker body (32) and base member (210) may haveany other suitable relationship.

Next, needle member (250) may be engaged with base member (210), asshown in FIG. 18. A marking element (34) may then be introduced throughneedle member (250). In particular, a marking element (34) may bedropped into top opening (254). The funnel-like configuration presentedby top opening (254) in the present example may serve as a guide formarking element (34), leading toward the interior opening of hollowneedle (256). The interior opening of hollow needle (256) may be sizedsuch that it is slightly larger than marking element (34), permittingmarking element (34) to pass through hollow needle (256). Prior toinsertion of needle member (250) into neck opening (220), thelongitudinal position of needle (256) may be adjusted such that the freetip of needle (256) will be located approximately at the center of amarker body (32) that is positioned in marker opening (218) when needlemember (250) is inserted into neck opening (220). Alternatively, the tipof needle (256) may be longitudinally positioned just before or justpast the center of marker body (32).

Then, after needle member (250) has been engaged with base member (210)as shown in FIG. 18 and a marking element (34) has been dropped into topopening (254), plunger (270) may be coupled with neck portion (214), asshown in FIG. 19. In particular, pin (276) may push marking element (34)completely through needle (256) and into marker body (32). Depending onthe longitudinal position of needle (256) and pin (256), this may resultin marking element (34) being positioned approximately at the center ofmarker body (32). Plunger (270) and needle member (250) may then bedisengaged from base member (210), thereby withdrawing pin (276) andneedle (256) from marker body (32), leaving marking element (34) withinmarker body (32).

Marker body (32) may then be removed from base member (210). Forinstance, head (232) of plug (230) may be pushed upward, such that stem(234) of plug (230) forces marker body (32) upward and into neck opening(220) where it can be easily extracted (e.g., pulled out, dumped out,etc.). Alternatively, plug (230) may be removed, and a poking instrumentmay be used to push marker body (32) upward and out through neck opening(220); or downward and out through plug opening (216). Other ways inwhich a marker body (32) may be removed from marker insertion device(200) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

It should be understood that marker insertion device (200), as well asmethods of using marker insertion device (200), may be varied innumerous ways. By way of example only, plug (230) may be omitted. Forinstance, plug opening (216) may be replaced by an opening that has asmaller diameter than a marker body (32). Such an alternative openingmay be small enough to restrict downward movement of marker body throughbase portion (212); yet be large enough to permit an instrument to beinserted therethrough to poke marker body (32) out through neck opening(220).

As another merely illustrative example of a variation for markerinsertion device (200), marker opening (218) may be positionedtransversely in base member (210). In other words, marker opening (218)may be oriented such that needle (256) and pin (276) may enter markerbody (32) transversely rather than longitudinally. It will also beappreciated that marker insertion device (200) may be coupled with apressing machine or other automated system, thereby automating the useof marker insertion device (200) to at least some degree. Still otherways in which marker insertion device (200) and its use may be variedwill be apparent to those of ordinary skill in the art in view of theteachings herein.

Embodiments of the present invention may have application inconventional endoscopic and open surgical instrumentation as well asapplication in robotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed an sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. An apparatus for inserting a marking element into a marker body, theapparatus comprising: (a) a marker body having a first length, whereinthe marker body comprises a bioresorbable portion; (b) a marking elementwherein the marking element is insertable into the marker body, whereinthe marking element has a second length, wherein the second length isless than the first length of the marker body; (c) a body portion havinga compartment, wherein the marker body is disposed in the compartment;(d) an insertion member, wherein part of the insertion member isinserted in the marker body within the compartment; and (e) a pushingmember, wherein the pushing member is configured to engage with theinsertion member, wherein the pushing member is operable to force themarking element along the insertion member into the marker body; whereinthe marker body containing the marking element is insertable into a bodycavity wherein the insertion member comprises a hollow needle; whereinthe pushing member comprises a pin configured to pass through at least aportion of the hollow needle; wherein the pushing member furthercomprises a pushing body portion, wherein the pin extends from thepushing body portion; wherein the position of the pin relative to thepushing body portion is adjustable; wherein the pushing member furthercomprises a fixation member, wherein the fixation member is operable toselectively secure the position of the pin relative to the pushing bodyportion.
 2. The apparatus of claim 1, wherein the needle has an open tipconfigured to penetrate the marker body.
 3. The apparatus of claim 1,wherein the needle has a tip and a length selected to position the tipapproximately at a center of the marker body.
 4. The apparatus of claim1, wherein the insertion member further comprises an insertion bodyportion, wherein the needle extends from the insertion body portion. 5.The apparatus of claim 4, wherein the position of the needle relative tothe insertion body portion is adjustable.
 6. The apparatus of claim 5,wherein the insertion member further comprises a set screw, wherein theset screw is operable to selectively secure the position of the needlerelative to the insertion body portion.
 7. The apparatus of claim 4,wherein the insertion body portion further comprises an opening incommunication with the needle, wherein the opening has a ramped surfaceconfigured to guide the marking element into the needle.
 8. Theapparatus of claim 1, wherein the marker body defines an axis.
 9. Theapparatus of claim 8, wherein the insertion member comprises an elongatemember configured to engage the marker body along the axis of the markerbody.
 10. The apparatus of claim 1, further comprising a plug memberconfigured to engage the body portion, wherein the plug member isconfigured to restrict longitudinal motion of the marker body within thecompartment.
 11. The apparatus of claim 10, wherein the plug member isconfigured to engage a first end of the marker body.
 12. The apparatusof claim 11, wherein the insertion member is configured to engage asecond end of the marker body.
 13. A method for inserting a markingelement into a marker body, the method comprising: (a) providing amarker insertion device having a body portion, wherein the body portioncomprises a compartment configured to receive a marker body; wherein themarker insertion device comprises: (a) a marker body having a firstlength, wherein the marker body comprises a bioresorbable portion; (b) amarking element wherein the marking element is insertable into themarker body, wherein the marking element has a second length, whereinthe second length is less than the first length of the marker body; (c)a body portion having a compartment, wherein the marker body is disposedin the compartment; (d) an insertion member wherein part of theinsertion member is inserted in the marker body within the compartment;and (e) a pushing member, wherein the pushing member is configured toengage with the insertion member, wherein the pushing member is operableto force the marking element along the insertion member into the markerbody; wherein the marker body containing the marking element isinsertable into a body cavity; wherein the insertion member comprises ahollow needle; wherein the pushing member comprises a pin configured topass through at least a portion of the hollow needle; wherein thepushing member further comprises a pushing body portion, wherein the pinextends from the pushing body portion; wherein the position of the pinrelative to the pushing body portion is adjustable; wherein the pushingmember further comprises a fixation member, wherein the fixation memberis operable to selectively secure the position of the pin relative tothe pushing body portion (b) inserting a marker body in the compartmentof the body portion, wherein the marker body comprises a bioresorbableportion; (c) inserting a hollow needle into at least a portion of themarker body while the marker body is located within the compartment; (d)introducing a marking element to the hollow needle; (e) inserting a pinthrough the hollow needle to drive the marking element through theneedle and into the marker body; (f) extracting the hollow needle fromthe marker body while the marking element remains within the markerbody; and (g) extracting the marker body from the compartment.
 14. Themethod of claim 13, wherein the marking element is radiopaque.
 15. Themethod of claim 13, comprising inserting the marker body containing themarking element into a marker deployment tool.